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Trial record 8 of 538 for:    Taste Disorders AND taste

Taste And Smell TEsting in End Stage Renal Disease (TASTE ESRD)

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ClinicalTrials.gov Identifier: NCT03043144
Recruitment Status : Withdrawn (Investigator leaving the institution)
First Posted : February 3, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Katherine Lynch, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date February 2, 2017
First Posted Date February 3, 2017
Last Update Posted Date June 26, 2017
Actual Study Start Date February 15, 2017
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2017)
change in lean body mass [ Time Frame: from 6 months to 1 year ]
lean body mass will be determined by dual-energy X-ray absorptiometry scan
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03043144 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 2, 2017)
  • change in hand grip strength [ Time Frame: from 6 months to 1 year ]
    measured by dynamometer
  • change in the physical function score [ Time Frame: from 6 months to 1 year ]
    measured by Standard-Form 36 version 2
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 16, 2017)
  • change in serum albumin [ Time Frame: from 6 months to 1 year ]
    change in serum albumin
  • change in dietary intake [ Time Frame: from 6 months to 1 year ]
    measured by a food frequency questionnaire
  • change in anthropometric measures [ Time Frame: from 6 months to 1 year ]
    triceps skinfold thickness, mid arm circumference, and weight
  • change in serum cholesterol [ Time Frame: from 6 months to 1 year ]
    change in serum cholesterol
Original Other Pre-specified Outcome Measures
 (submitted: February 2, 2017)
  • change in serum albumin [ Time Frame: from 6 months to 1 year ]
  • change in dietary intake [ Time Frame: from 6 months to 1 year ]
    measured by a food frequency questionnaire
  • change in anthropometric measures [ Time Frame: from 6 months to 1 year ]
    triceps skinfold thickness, mid arm circumference, and weight
  • change in serum cholesterol [ Time Frame: from 6 months to 1 year ]
 
Descriptive Information
Brief Title Taste And Smell TEsting in End Stage Renal Disease
Official Title TASTE ESRD: Taste And Smell TEsting in End Stage Renal Disease
Brief Summary Malnutrition is an important complication of advanced kidney disease and impairment in smell and taste may affect nutritional status. This study will examine the association between impairment in smell and taste and nutritional and functional markers among patients with end stage renal disease, as well as risk factors for smell and taste impairment.
Detailed Description

People with advanced chronic kidney disease (CKD) are at risk for malnutrition, which is associated with significantly increased mortality. Impairments in olfaction and taste are under-recognized and under-addressed symptoms that affect this population. Olfaction and taste influence appetite and nutritional status and represent a unique target for study and intervention. Small cross-sectional studies have shown a higher prevalence of olfactory (up to 56%) and taste disturbances (up to 35%) among patients with CKD compared with the general population, but little is known about longitudinal change in olfaction and taste in this population. Additionally, there is a lack of understanding about why these sensory disturbances more commonly occur in people with CKD, although there is speculation that uremia may contribute.

This information gained from this study will address these gaps in knowledge by studying longitudinal changes in olfaction and taste and their associations with concurrent and future nutritional and functional status. Additionally this study will attempt to identify potentially modifiable risk factors associated with olfactory and taste impairment.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults (aged 18 or older) who have end-stage renal disease requiring chronic dialysis.
Condition
  • Kidney Failure, Chronic
  • Olfaction Disorders
  • Taste Disorders
  • Malnutrition
Intervention
  • Other: Worsening of olfaction from enrollment visit to 6 months
    Worsening of olfaction from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes
  • Other: Worsening of taste from enrollment visit to 6 months
    Worsening of taste from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes
  • Other: Serum Zinc
    Serum zinc will be evaluated for association with taste and/or smell impairment
  • Other: Chronic rhinosinusitis
    Chronic rhinosinusitis will be evaluated for association with smell impairment
  • Other: Dialysis adequacy
    Dialysis adequacy will be evaluated for association with taste and/or smell impairment
  • Other: Decayed missing filled teeth index (DMFT)
    DMFT will be evaluated for association with taste impairment
Study Groups/Cohorts End stage renal disease
Observational study, no intervention
Interventions:
  • Other: Worsening of olfaction from enrollment visit to 6 months
  • Other: Worsening of taste from enrollment visit to 6 months
  • Other: Serum Zinc
  • Other: Chronic rhinosinusitis
  • Other: Dialysis adequacy
  • Other: Decayed missing filled teeth index (DMFT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: June 22, 2017)
0
Original Estimated Enrollment
 (submitted: February 2, 2017)
135
Actual Study Completion Date April 1, 2017
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Aged 18 or older
  • End-stage renal disease requiring chronic dialysis

Exclusion Criteria:

  • Known allergy to quinine
  • Presence of a pacemaker or internal defibrillator
  • Pregnancy or breastfeeding
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03043144
Other Study ID Numbers 2016P000152
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Katherine Lynch, Beth Israel Deaconess Medical Center
Study Sponsor Beth Israel Deaconess Medical Center
Collaborators National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Katherine Lynch, MD, SM Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date June 2017